Magni-v6®

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT MAGNE-В6® (MAGNE-В6®)

Composition:

Active substances: magnesium, pyridoxine;

One tablet contains magnesium lactate dihydrate 470 mg (corresponding to 48 mg of Mg²⁺, or 1.97 mmol) and pyridoxine hydrochloride (vitamin B6) 5 mg;

Excipients: sucrose, kaolin, acacia, carbomer, talc, magnesium stearate;

Coating: acacia, sucrose, titanium dioxide (E 171), talc, carnauba wax.

Medicinal form. Coated tablets.

Main physicochemical characteristics: white, smooth, shiny, oval coated tablets.

Pharmacotherapeutic group. Agents affecting the digestive system and metabolism. Vitamins. Vitamin B complex preparations, including combinations. Vitamin B complex with minerals.

ATC code A11E C.

Pharmacological properties.

Pharmacodynamics.

Magnesium is an intracellular cation that reduces neuronal excitability and inhibits neuromuscular transmission, as well as participates in numerous enzymatic reactions. Magnesium is an essential component of body tissues: skeletal bones contain half of the total amount of magnesium present in the body.

A serum magnesium concentration between 12 and 17 mg/L (1–1.4 mEq/L, or 0.5–0.7 mmol/L) indicates moderate magnesium deficiency; below 12 mg/L (1 mEq/L, or 0.5 mmol/L) indicates severe magnesium deficiency.

Magnesium deficiency may be:

• primary, due to metabolic pathology (chronic inherited hypomagnesemia);
• secondary, due to:
  • inadequate dietary magnesium intake (poor nutrition, chronic alcohol abuse, exclusive parenteral nutrition);
  • impaired magnesium absorption in the gastrointestinal tract (chronic diarrhea, gastrointestinal fistulas, hypoparathyroidism);
  • excessive magnesium loss via renal excretion (tubular disorders, severe polyuria, diuretic abuse, chronic pyelonephritis, primary hyperaldosteronism, treatment with cisplatin).

Pharmacokinetics.

Absorption of magnesium salts in the gastrointestinal tract involves, among other mechanisms, a passive process for which the solubility of the salt is a determining factor.

Gastrointestinal absorption of magnesium salts does not exceed 50%. Magnesium is primarily excreted in the urine.

Clinical characteristics.

Indications.

Treatment of confirmed magnesium deficiency in the body, either isolated or associated with other deficiency states.

Contraindications.

Hypersensitivity to any component of the drug. Severe renal insufficiency with creatinine clearance less than 30 ml/min. Phenylketonuria. Hypermagnesemia, hypervitaminosis of vitamin B6, myasthenia gravis. Atrioventricular block, severe arterial hypotension. Concomitant use with levodopa (see section "Interaction with other medicinal products and other types of interactions"). Diarrhea. Fructose intolerance, glucose-galactose malabsorption syndrome, sucrase-isomaltase deficiency (due to the presence of sucrose in the drug).

Interaction with other medicinal products and other types of interactions.

Contraindicated combinations.

Concomitant use with levodopa should be avoided, as levodopa activity is inhibited when administered without concomitant use of peripheral dopa-decarboxylase inhibitors. Pyridoxine administration in any dosage is not recommended if levodopa is not administered together with dopa-decarboxylase inhibitors.

Not recommended combinations.

Do not use with medicinal products containing phosphate or calcium salts, as they suppress magnesium absorption from the intestine.

Combinations requiring caution.

Use oral tetracyclines with caution, as magnesium reduces tetracycline absorption from the stomach and intestine. When used concomitantly with oral tetracyclines, administration of Magne-B6® should be delayed by at least 3 hours.

Magnesium preparations reduce the effect of oral anticoagulants and decrease iron absorption.

Diuretics increase urinary excretion of magnesium.

Use of hydralazine, isoniazid, penicillamine, and oral contraceptives increases the requirement for vitamin B6.

Special precautions for use.

In patients with severe magnesium deficiency, treatment with this medicinal product should be initiated by intravenous administration. This is also indicated in patients with malabsorption.

In patients with concomitant calcium deficiency, correction of magnesium deficiency should generally be performed before calcium supplementation.

Since this medicinal product contains sucrose, it is contraindicated in patients with hereditary fructose intolerance, glucose-galactose malabsorption syndrome, or sucrase-isomaltase deficiency.

Information for patients with diabetes mellitus: the film-coated tablets contain sucrose as an excipient.

Abuse of pyridoxine may lead to the development of sensory neuropathy when administered in high doses (> 200 mg/day) over a prolonged period (i.e., several months or years). Symptoms include numbness, sensory disturbances, tremor, and gradually progressive sensory ataxia (coordination problems). This effect is usually reversible and resolves after discontinuation of the drug.

Precautions for use

THIS MEDICINAL PRODUCT IS INTENDED FOR USE IN ADULTS AND CHILDREN AGED 6 YEARS AND OLDER ONLY.

For children under 6 years of age, appropriate dosage forms are available.

Patients with moderate renal impairment should take precautions to prevent any risks associated with hypermagnesemia.

Use during pregnancy or breastfeeding.

Pregnancy. Limited clinical data from animal studies have not revealed any fetotoxic or embryotoxic effects of the drug. Therefore, magnesium may be used during pregnancy only when necessary and after consultation with a physician.

Breastfeeding period. Each of the active ingredients of the drug separately (both magnesium and vitamin B6) is not contraindicated during this period. However, due to limited evidence regarding the use of the maximum recommended daily dose of vitamin B6 during breastfeeding, it is recommended not to exceed 20 mg/day of vitamin B6.

Ability to influence reaction rate when driving or operating machinery. The medicinal product Magnesium B6®, film-coated tablets, has no effect or negligible effect on the ability to drive or operate machinery.

Dosage and Administration.

Tablets should be swallowed whole with one glass of water.

Adults: 6–8 tablets per day, divided into 2 or 3 doses taken during meals.

Children aged 6 years and older (with body weight over 20 kg): 10–30 mg/kg body weight per day (i.e., 0.4–1.2 mmol/kg body weight per day), corresponding to 4–6 tablets per day, divided into 2 or 3 doses taken during meals.

Treatment should be discontinued as soon as magnesium blood levels return to normal.

Children. The drug is indicated for children aged 6 years and older. For children under 6 years of age, appropriate dosage forms are available.

Overdose.

Magnesium-related

Magnesium overdose following oral administration usually does not lead to toxic reactions in patients with normal renal function. However, in patients with renal insufficiency, magnesium intoxication may develop.

Toxic effects depend on serum magnesium levels and are manifested by the following signs:

• marked decrease in arterial blood pressure;
• nausea, vomiting;
• central nervous system depression, impaired reflex functions;
• pathological changes on ECG;
• respiratory depression, coma, cardiac arrest, and respiratory paralysis;
• anuria.

Treatment of overdose: rehydration and forced diuresis. Hemodialysis or peritoneal dialysis is required for patients with renal insufficiency.

Pyridoxine-related

Sensory axonal neuropathy is the main adverse effect that may occur during prolonged and/or chronic administration of high pyridoxine doses (over several months or years).

Signs and symptoms

In particular, paresthesia, dysesthesia, hypoesthesia, sensory deficits, limb pain, involuntary muscle contractions, burning sensations, impaired balance, gait disturbances, hand and leg tremors, and progressive sensory ataxia (difficulty coordinating movements) have been reported.

Treatment

Neurological symptoms gradually resolve after discontinuation of treatment.

Adverse Reactions.

The adverse reactions that may occur during the use of Magne-B6® coated tablets are listed below by organ system class and frequency: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1000, < 1/100); rare (≥ 1/10 000, < 1/1000); very rare (< 1/10 000); frequency not known (cannot be estimated from available data).

Immune system disorders.

Frequency not known: allergic reactions, hypersensitivity, angioedema.

Gastrointestinal disorders.

Frequency not known: diarrhea*, nausea, vomiting, abdominal pain*.

Skin and subcutaneous tissue disorders.

Frequency not known: skin reactions, including urticaria, pruritus, eczema, erythema.

* Adverse reactions associated with magnesium.

Reporting of suspected adverse reactions.

Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any adverse reactions via the national pharmacovigilance system.

Shelf life. 2 years.

Storage conditions.

Store at temperatures not exceeding 25 °C. Keep out of reach and sight of children.

Packaging.

No. 60 (20 × 3): 20 tablets in a blister, 3 blisters in a cardboard box.

Prescription status. Over-the-counter.

Manufacturers.

SANOFI WINNERTHUR INDUSTRIES, FRANCE.

Opella Hejeskai Kft., Hungary.

Manufacturers' locations and addresses of sites of manufacturing activity.

1 rue de la Vierge Ambarès et Lagrave 33565 CARBON BLANC CEDEX, France.

Levai str. 5, Veresegyhaz, 2112, Hungary.

Marketing Authorization Holder.

LLC "Opella Hejeskai Ukraine", Ukraine.

Address of the Marketing Authorization Holder and/or its representative.

48-50A Zhylianska St., Kyiv, 01033, Ukraine.